Status:
COMPLETED
Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke
Lead Sponsor:
Dexa Medica Group
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3 months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome in patients ...
Detailed Description
There will be 3 groups of treatment; each group will consist of 43 subjects with the treatment regimens : * Treatment I : 1 tablet of DLBS1033 490 mg thrice daily, after meal * Treatment II : 1 table...
Eligibility Criteria
Inclusion
- Male and female subjects aged 20-80 years old
- Having non-bleeding stroke in CT scan examination
- Having stroke attack onset ≤ 96 hours
- Living in 100 km from RSUP Dr Sardjito Jogjakarta
Exclusion
- Having recurrence stroke
- Having Transient Ischemic Attack (TIA)
- Have been regularly taking anti-aggregation agent
- Having intracerebral and subarachnoid bleeding stroke
- Subjects and their family do not know when the stroke symptoms appeared
- History of haemostasis disorder
- History of or will have surgery within 6 months prior to screening
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT01790997
Start Date
May 1 2012
End Date
December 1 2013
Last Update
June 4 2014
Active Locations (1)
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1
Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital
Yogyakarta, Jogjakarta, Indonesia, 55281